Abstract
In recent years, there has been an increasing use of modeling and simulation (M&S) within the pharmaceutical industry, along with increasing acceptance of M&S in pediatric drug development by regulatory agencies. Moreover, an increasing body of physiologic, biological, and pharmacologic data has become available to inform neonatal modeling. Developing complementary M&S frameworks for neonates is warranted to support first-in-neonate dose selection and expedite successful neonatal drug development.
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